The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-suture Kit.
| Device ID | K933137 |
| 510k Number | K933137 |
| Device Name: | ACU-SUTURE KIT |
| Classification | General Surgery Tray |
| Applicant | ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Contact | Charles Yeh |
| Correspondent | Charles Yeh ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale, FL 33309 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1994-02-22 |